PDUFA IV 5-Year Financial Plan (2008): CDER Plan Summary

CDER plans for FY 2008 and the subsequent fiscal years authorized in PDUFA IV are summarized below, using the PDUFA IV funding base and increase categories.

Increases to the PDUFA IV Funding Base

In FY 2008, CDER plans to increase review staffing by about 220 FTE, just to sustain the work necessary to continue to meet PDUFA III performance goals that are incorporated into PDUFA IV. Under PDUFA III, funding levels did not keep up with increases in workload and therefore CDER employed fewer review staff than needed to meet goals. This led to CDER’s inability to meet some goals and to insufficient staffing levels to be able to provide necessary staff development opportunities.

The additional PDUFA IV base funds will be used to hire needed drug review staff and to provide training opportunities to existing staff to sustain performance toward the PDUFA review goals. The additional staff are also necessary to ensure that CDER can address the growing workload associated with increased Investigational New Drug submissions, special protocol assessments, and meeting requests. In addition, the new fee resources allow CDER to ensure that scientists and medical officers have opportunities to participate in and attend professional development and training activities so that they can remain current in scientific and medical technology.

Critical Path

CDER will hire an additional 19 staff in 2008 to work on critical path objectives, and these staff will be supported through FY 2012.

FDA will use the funds to support specific projects to modernize FDA regulatory standards and strategies. Most projects will extensively leverage other Federal, private sector and philanthropic resources to complete the tasks.

To update the regulatory standards and review for new human drugs, FDA will:

Continue development of public private partnerships to advance biomarker development, understanding of the genetic basis of serious adverse events, predictive safety, and opportunities to improve the conduct of clinical trials.

Broaden projects with NIH and various other stakeholders to evaluate the effectiveness of individualized dosing using pharmacogenomic information.

Collaborate on developing new biomarkers for acute cardiovascular risks (i.e., stroke, MI) that can be used to identify and study people at high risk.

Study additional biomarkers for individualizing cancer treatment, to avoid patient exposure to ineffective therapy, and to increase chances for beneficial response to treatment.

Launch the Sentinel Initiative to provide a national, integrated, electronic mechanism by which FDA will be able to query multiple exiting data sources.

Modernize the Agency’s bioresearch monitoring programs.

Continue critical efforts on the bioinformatics initiative, including modeling and simulation.

Promote use of quality systems drug development, regulation, and manufacturing, including developing new methods technologies and standards to improve manufacturing quality.

Develop risk-based approaches to guide the prioritization of inspections.

Drug Safety /Risk Management

The center will hire an additional 73 staff and $6 million in contract funds in 2008 to work on drug safety/risk management objectives, and these staff and contract funds will be supported through FY 2012.

With these funds, CDER will be able to increase the number of employees dedicated to safety evaluation of marketed medications. CDER will also be able to add resources for adopting new scientific approaches to drug safety, reducing the risk of medication errors, improving the utility of existing tools for detection and prevention of adverse events, and incorporating the new approaches into the Agency’s drug safety program.

With these new resources CDER will:

Develop and periodically update a 5-year plan describing activities that will lead to enhancing and modernizing FDA’s drug safety activities/system;

Assess current and new methodologies to collect adverse event information at various points during the product lifecycle;

Identify epidemiology best practices and develop guidance(s) describing these practices;

Expand database acquisition to be used for targeted post-marketing surveillance and epidemiology;

Develop and validate risk management and risk communication tools; and

Improve post-market information technology systems.

Further CDER will work to meet its commitments to increase the timely and consistent review of new drug trade names to prevent name confusion, including:

Developing two new guidance documents to industry regarding: 1) contents of a complete submission package; and 2) best practices for naming, labeling and packaging;

Establishing review goals and timelines;

Conducting a pilot program to evaluate new Proprietary Name review paradigm; and

Providing the public the full source code for the Agency’s Phonetic and Orthographic Computer Analysis (POCA) tool (used by FDA to assess potential name confusion).

Additional Drug Safety Increase

The center will hire an additional 68 staff in 2008 to work on additional drug safety objectives. Additional staff for this purpose will increase steadily each year, as shown in the table below.

Additional CDER FTE for Additional Drug Safety Increases by Year

Fiscal Year

2008

2009

2010

2011

2012

CDER FTE

68

95

122

149

176

In addition, CDER will have about $5 million available for Congressional drug safety contract initiatives in FY 2008, growing steadily to a total of almost $22 million in FY 2012.

CDER will use these additional resources to increase the Center’s capacity for handling new authorities and requirements of the FDA Amendments Act of 2007, including (as examples) efforts associated with implementing Risk Evaluation and Mitigation Strategies (REMS), Post-Market Study/Trial Requirements, Safety Labeling Changes, Active Postmarket Risk Identification, and other provisions.